Pain palliation measurement in cancer clinical trials: The US Food and Drug Administration perspective
Abstract
Pain palliation resulting from antitumor therapy provides direct evidence of treatment benefit when combined with evidence of antitumor activity. The US Food and Drug Administration (FDA) previously issued guidance regarding the use of patient‐reported outcome (PRO) measures to support labeling claims. The purpose of this article is to identify common challenges and key design strategies when measuring pain palliation in antitumor therapy clinical trials that are consistent with PRO Guidance principles.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Dec 05, 2013
- Source ID
- 10.1002/cncr.28470
Entities
People
- Ann Marie Trentacosti
- Elektra Papadopoulos
- Ethan Basch
- Harry Smith
- James P. Stansbury
- Karen A. Autio
- Laurie B. Burke
- Paul G. Kluetz
- Richard Pazdur
- Robert C. Kane
- Robert Justice
- Virginia Kwitkowski
Organizations
- Food and Drug Administration
- Memorial Sloan Kettering Cancer Center
- United States Department of Defense
- University of North Carolina at Chapel Hill